Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)

Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South

Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. The primary outcomes will be feasibility, acceptability, and usability of the intervention. Secondary outcomes will be increased coping skills and resilience, which in turn, will increase status neutral HIV and HCV care and MOUD uptake (longer-term outcomes). Outcomes will be assessed using pre- and post-intervention surveys.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder; HEPATITIS C (HCV); HIV Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)

Detailed Description

The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Rifat Haider, Ph.D.; Phone Number: 803-477-4289; Email: haider@uga.edu

Study Locations

• United States
  • Georgia
    • Colbert, Georgia, United States, 30628
      • MedLink Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Investigators will conduct in-depth interviews with adult (≥18 years) PWID who are HIV negative and living in rural areas with representation from all genders and races/ethnicities and 15 key informants (i.e., providers, policymakers) for in-depth interviews.

Description

Inclusion Criteria:

• People who actively inject drugs verified by visible injection stigmata (needle tracks)
• HIV negative
• Adult (≥18 years)
• lives in rural areas

Exclusion Criteria:

• Living with HIV
• Lives in urban areas
• Not proficient in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID); The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e. g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.
Active Comparator: Waitlist Control; Control	Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID); The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e. g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Intervention	Feasibility of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Feasibility will be assessed by the completion rates of the interventionist training sessions and the participation/drop-out rates of the PWID.	Months 31-60
Acceptability of the telehealth intervention	Acceptability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Acceptability will be examined by Likert scale like responses, e.g., "convenient," "a nuisance," "easy to use," and "time-consuming."	Months 31-60
Usability of the telehealth intervention	Usability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Usability will be assessed with the USE questionnaire, which captures the perceived usefulness, satisfaction, and ease of use.	Months 31-60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	The Center for Epidemiologic Studies Depression (CES-D) Scale (20 items) will be used to measure depressive symptoms. CES-D Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Months 31-60
Resilience	The 10-item Connor-Davidson Resilience Scale (CD-RISC) scale will be used to measure resilience. Scores range from 0-40, where higher scores indicate greater resilience.	Months 31-60
Intersecting stigma of HIV, HCV, and drug use	The 16-item Anticipated HIV Stigma Scale will be used to measure HIV stigma. Scores range from 16-64, where higher scores reflect higher stigma. The 33-item HCV Stigma Scale (HCV-SS) will be used to measure HCV-related stigma. The total score range for this scale is 33 to 132, with higher scores indicating greater perceived stigma. The 8-item Perceived Stigma of Substance Abuse Scale (PSAS) will be used to measure the drug use stigma. Scores range from 8-32, where a higher score reflects higher stigma. Intersectional stigma scores will be calculated using the formula, d = square root of (a-squared + b-squared + c-squared), where d is the intersectional stigma score, and a is the HIV-related stigma score, b is the HCV-related stigma score, and c is the drug use stigma score. The score ranges from 37.5-150.2, and the higher the score, the higher the intersecting stigma.	Months 31-60
Sexual behavior	Sexual practices like protected sex, risky sex (sex under the influence, sex in return of drugs/money, unprotected anal/vaginal sex, multiple partners, not knowing partnmer's HIV status)	Months 31-60
Risky Injection Bheavior	Risky injection behavior includes the sharing of syringes, using same syringe multiple times	Months 31-60

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: People who inject drugs (PWID); Hepatitis C Virus; HIV Pre-Exposure Prophylaxis; Medications for Opioid Use Disorder; Telehealth Intervention; Deep South
• Additional Relevant MeSH Terms: Blood-Borne Infections; Narcotic-Related Disorders; Mental Disorders; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Flaviviridae Infections; Hepatitis; Opioid-Related Disorders; Hepatitis C
• Other Study ID Numbers: PROJECT000009015; K01DA059329 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators will not share the IPD of the participants of this study due to the risk of privacy breach for the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No